Coloplast Biatain STD Alginate 10x10cm
Brand(s)
Last updated
Summary
Product
Coloplast Biatain STD Alginate 10x10cm
Issue
Medical devices - Sterility
What to do
Contact the manufacturer if you require additional information.
Audience
Industry
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Coloplast Biatain Std Alginate 10x10cm | W000070556 W00069434 W000068269 W00068634 | 3710 3715 |
Issue
On 25th July AMS staff identified a defect on primary packaging pouches, during packaging, of minor missing patches of polyethylene. The defect could compromise the device's ability to maintain a sterile barrier. In addition, patches of burnt or cracked polyethylene have been identified on the inside face of the primary.
AMS is the contract manufacturer for the Coloplast branded labels.
Recall start date: October 14, 2024
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General and plastic surgery
Companies
| Coloplast A/S |
| Holtedam 1, Humlebaek, Denmark, 3050 |
Published by
Health Canada
Audience
Industry
Recall class
Type II
Identification number
RA-76828
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